THe USA vs the EU: Which Has More Expensive Drug Trias?

It is a common belief (in the USA) that one reason for the high cost of new therapeutic drugs, is the great expense and time involved in having the FDA approve the new medicine. By contrast, I have heard that the EU has faster and less costly approval trials…is this correct?
By way of example, MERCK claims that a new anti-cholesterol drug will cost $85 million for clinical trials alone!
Is this issue a mojor reason why drugs cost more in the USA?

There is no such thing as an “EU drug trial.” The drug approval process in the EU countries is not harmonized, and many member countries will not approve a drug unless trials have been conducted in that country. They also have different requirements for setting up the trials, so even if they accept foreign trials, the conditions must meet the requirements of all the target countries. This multiple trial protocol adds a lot of expense to getting a drug approved. On the other hand, the cost of running each trial is lower, since American investigators (doctors) tend to demand more money for participating in trials. The agencies in most European countries are also less antagonistic than the FDA; their willingness to advise drug developers prior to filing an application reduces the cost of errors and misunderstandings.

I think it comes out roughly even.

I don’t know the specific differences or how common it is, but there are American companies that run large parts of their drug trials in Germany. According to them, it’s faster and cheaper that way, but this could be limited to certain kind of trials.

I was on the phone with my mother the pharmacist about this exact topic last night. She says that up until about 10 years ago, that was exactly the case for why drugs were so expensive. Drug companies had few other expenditures. Now, the amount of money spent on advertising has doubled that of R&D (according to her).

I don’t think she’d be too keen on digging up an internet citation for that, since she can barely work the e-mail. Hopefully someone with more direct knowledge will be able to fill in the gaps.

I used to have a job translating European clinical trial (what are classified as Phase I - Phase IV, at least in the US) cost lists from French & German into English. :o Imagine a room of 20 people doing this all day, silently… I quit after 6 months!

The reason for creating the database we were creating was precisely that pharm corporations were shopping around for the best deals for where to do their clinical trials based upon the frequency and charges involved in each test. As I understood it, EU nations would generally accept the results from other EU nations in terms of getting approval for the drugs in question, although at the time (1998) there was still seperate filing concerns for each nation (i.e. no one body to which the corp. could apply for approval for all nations in the EU). Pehaps that’s changed? Honestly I was hoping never to have to think about it again… :slight_smile:

The cheapest place to do each trial could vary greatly according to how much the test facility or doctor charged per each test (say a blood pressure reading, or a whole physical, or certain types of blood work) multiplied by how frequently each needed to be done over the course of the trial.

The fact we offered a US database as a seperate product (in fact the same product as a database interface, but seperate sets of data) suggests to me the FDA wants clinical trials to happen in the US for drugs approved here. ??? [Dr. Evil voice] I’m not really what you’d call an “implimentor.”[/Dr. Evil voice]

As far as advertising dwarfing R&D, that sounds right. Link from AFL-CIO.

Americans subsidize the industry to a ridiculous extent, and prices seem way higher to me than is reasonable. People are willing to pay quite a lot to stay out of pain or not kick the bucket. This link is a quick overview of the numbers involved which involved two Republican Congressmen.

Looks we have some bipartisan agreement on Americans getting pretty well ripped off… the answer to the cost portion of your question is simple gouging IMO.

I don’t work in regulatory affairs, so I don’t know all the details, but the EU countries are certainly becoming more consistent from country to country regarding the acceptance of drug trials, with the EMEA organization and the ICH (International Conference on Harmonization) guidelines.